Drugs / Mirvetuximab Soravtansine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Elahere | — | 2024-11-14 | europa.eu ↗ |
| Label expansion | US (FDA) | ELAHERE | — | 2024-03-22 | fda.gov ↗ |
| Approved | US (FDA) | ELAHERE | — | 2022-11-14 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07218809 Comparator | Dec 2025 → Nov 2028 expected | ovarian epithelial tumor | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07213804 Comparator | Oct 2025 → Nov 2028 expected | fallopian tube neoplasm, metastatic neoplasm, ovarian neoplasm, peritoneal neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
Press releases naming this drug 49 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-12 | AbbVie | AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026 abbvie.com ↗ |
| 2025-09-29 | AbbVie | AbbVie Announces UK Pricing Strategy for ELAHERE® (mirvetuximab soravtansine-gynx) abbvie.com ↗ |
| 2025-03-15 | AbbVie | ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients abbvie.com ↗ |
| 2024-11-18 | AbbVie | AbbVie Receives European Commission Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2024-09-20 | AbbVie | AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer abbvie.com ↗ |
| 2024-06-06 | AbbVie | AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer abbvie.com ↗ |
| 2024-03-22 | AbbVie | U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients abbvie.com ↗ |
| 2023-12-05 | AbbVie | FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2023-11-30 | AbbVie | AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio abbvie.com ↗ |
| 2023-10-27 | AbbVie | ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2022-11-14 | AbbVie | ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2022-10-28 | AbbVie | ImmunoGen Presents Retrospective Analysis of Extended Treatment Benefit from Multiple Trials of Mirvetuximab Soravtansine in Ovarian Cancer at ESGO abbvie.com ↗ |
| 2022-09-29 | AbbVie | ImmunoGen Presents Comprehensive Updates for Mirvetuximab Soravtansine Combination Data in Ovarian Cancer at IGCS abbvie.com ↗ |
| 2022-09-11 | AbbVie | ImmunoGen Presents Additional Analyses Evaluating Mirvetuximab Soravtansine in Ovarian Cancer at ESMO abbvie.com ↗ |
| 2022-05-26 | AbbVie | ImmunoGen Presents Additional Efficacy and Safety Analyses Evaluating Mirvetuximab Soravtansine in Ovarian Cancer at ASCO abbvie.com ↗ |
| 2022-05-23 | AbbVie | ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review abbvie.com ↗ |
| 2022-03-29 | AbbVie | ImmunoGen Submits Biologics License Application to the US Food and Drug Administration for Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗ |
| 2022-03-19 | AbbVie | ImmunoGen Presents Full Results from Positive Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer at SGO Annual Meeting abbvie.com ↗ |
| 2022-03-10 | AbbVie | ImmunoGen to Present Full Results from SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer at the Society of Gynecologic Oncology Annual Meeting abbvie.com ↗ |
| 2021-11-30 | AbbVie | ImmunoGen Announces Positive Top-Line Results from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗ |
| 2021-05-19 | AbbVie | ImmunoGen Announces Mature Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗ |
| 2020-10-19 | AbbVie | ImmunoGen and Huadong Medicine Announce Strategic Collaboration to Develop and Commercialize Mirvetuximab Soravtansine in Greater China abbvie.com ↗ |
| 2020-09-17 | AbbVie | ImmunoGen Presents Final Data From Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination With Carboplatin and Avastin® at ESMO abbvie.com ↗ |
| 2020-05-29 | AbbVie | ImmunoGen Presents Initial Data at ASCO from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗ |
| 2020-05-13 | AbbVie | ImmunoGen Announces Initial Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status abbvie.com ↗ |
| 2019-12-17 | AbbVie | ImmunoGen Announces Accelerated Approval Pathway for Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗ |
| 2019-09-29 | AbbVie | ImmunoGen Presents Initial Data from Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination with Carboplatin and Avastin® at ESMO abbvie.com ↗ |
| 2019-09-17 | AbbVie | ImmunoGen to Present Full Data from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine and Initial Data from Phase 1b FORWARD II Triplet Cohort at ESMO abbvie.com ↗ |
| 2019-05-15 | AbbVie | ImmunoGen Provides Regulatory Update on Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer abbvie.com ↗ |
| 2019-05-15 | AbbVie | ImmunoGen Announces Mature Data from FORWARD II Expansion Cohort Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Ovarian Cancer abbvie.com ↗ |
| 2019-03-01 | AbbVie | ImmunoGen Announces Top-Line Results from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine in Ovarian Cancer abbvie.com ↗ |
| 2018-10-20 | AbbVie | ImmunoGen Presents Initial Data from FORWARD II Expansion Cohort Assessing Mirvetuximab Soravtansine in Combination with KEYTRUDA at ESMO 2018 Congress abbvie.com ↗ |
| 2018-10-08 | AbbVie | ImmunoGen to Present Initial Data from FORWARD II Expansion Cohort of Mirvetuximab Soravtansine in Combination with KEYTRUDA at ESMO abbvie.com ↗ |
| 2018-06-18 | AbbVie | ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2018-05-16 | AbbVie | ImmunoGen Announces Positive Findings from the FORWARD II Study of Mirvetuximab Soravtansine Combination Regimens with Avastin® and Carboplatin in Ovarian Cancer abbvie.com ↗ |
| 2018-04-26 | AbbVie | ImmunoGen Announces Successful Completion of Interim Analysis for FORWARD I Phase 3 Trial of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2018-03-24 | AbbVie | ImmunoGen Presents Data from FORWARD II Assessment of Mirvetuximab Soravtansine in Combination with Pembrolizumab at the Society of Gynecologic Oncology Annual Meeting abbvie.com ↗ |
| 2017-05-17 | AbbVie | ImmunoGen Announces New Clinical Data with Mirvetuximab Soravtansine in Ovarian Cancer to be Presented at 2017 ASCO Annual Meeting abbvie.com ↗ |
| 2017-05-01 | AbbVie | ImmunoGen Announces Results from Mirvetuximab Soravtansine Phase 1 First-in-Human Dose-Escalation Trial Published in Cancer abbvie.com ↗ |
| 2017-01-26 | AbbVie | ImmunoGen Announces First Patient Dosed in FORWARD I Phase 3 Study of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2016-12-28 | AbbVie | ImmunoGen Announces Mirvetuximab Soravtansine Phase 1 Expansion Cohort Results in Platinum-Resistant Ovarian Cancer Published in the Journal of Clinical Oncology abbvie.com ↗ |
| 2016-11-11 | AbbVie | ImmunoGen to Present Preclinical Data Highlighting Potential of Combining Mirvetuximab Soravtansine with an Immune Checkpoint Inhibitor at SITC 2016 Annual Meeting abbvie.com ↗ |
| 2016-05-18 | AbbVie | ImmunoGen Reports Efficacy and Safety Data from a 46-Patient Cohort of Mirvetuximab Soravtansine in FRα-Positive Ovarian Cancer abbvie.com ↗ |
| 2016-02-04 | AbbVie | ImmunoGen and Merck Establish Collaboration for Clinical Evaluation of Mirvetuximab Soravtansine in Combination with Keytruda® (pembrolizumab) for the Treatment of Ovarian Cancer abbvie.com ↗ |
| 2015-11-08 | AbbVie | Treatment Response to ImmunoGen's Mirvetuximab Soravtansine Found to be Substantially Greater in Ovarian Cancer with High Expression of Folate Receptor Alpha abbvie.com ↗ |
| 2015-05-30 | AbbVie | ImmunoGen's Mirvetuximab Soravtansine (IMGN853) Demonstrates Notable Single Agent Activity for Patients with Platinum-Resistant Ovarian Cancer abbvie.com ↗ |
| 2013-06-03 | AbbVie | First Clinical Data Presented with IMGN853, ImmunoGen, Inc.'s Potential New Therapy for Ovarian and Other Cancers abbvie.com ↗ |
| 2012-07-11 | AbbVie | ImmunoGen, Inc. Initiates Phase I Trial of IMGN853 in Ovarian Cancer and Other Solid Tumors Over-Expressing Its Folate Receptor Target abbvie.com ↗ |
| 2012-04-17 | AbbVie | ImmunoGen, Inc. Announces the IND Is Now Active for Its Folate-Receptor Targeting Anticancer Compound, IMGN853 abbvie.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirvetuximab Soravtansine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06682988 ↗ |
| Known as | IMGN853 | “A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With...” NCT02631876 ↗6“Carboplatin (AUC5, d1) + Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV d1 x 6 cycles q21d, followed by subsequent monotherapy of Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV...” NCT04274426 ↗ “Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer” NCT03552471 ↗ “Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗ “Mirvetuximab Soravtansine (IMGN853)” NCT03045393 ↗ |
| Known as | MIRV | “OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 20255“Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent...” PMID 33667670 ↗ Mar 2021 “Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC)” NCT04606914 ↗ “Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC.” NCT07059845 ↗ “Mirvetuximab Soravtansine (MIRV)” NCT07218809 ↗ |
| Known as | mirvetuximab | “Mirvetuximab soravtansine is a monoclonal antibody, called mirvetuximab, linked to a chemotherapy drug called DM4.” NCT02996825 ↗ |
| Known as | mirvetuximab soravtansine-gynx | “BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with United States Food and Drug...” PMID 39617145 ↗ Nov 20243“OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients...” PMID 40700855 ↗ Jul 2025 “Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate, comprises a folate receptor alpha (FRα)-binding antibody and tubulin-targeting payload (maytansinoid DM4).” PMID 39082675 ↗ Jul 2024 |
| Known as | TAK-853 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06390995 ↗ |
| Action | Deplete | “may help find certain tumor cells and kill them without harming normal cells.” NCT03552471 ↗ |
| Modality | Other / unclassified | “Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with...” PMID 40700855 ↗ Jul 2025 |
| Route | Intravenous | “Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.” NCT01609556 ↗ |
| Target | FOLR1 | “Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way” NCT02996825 ↗ |